An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Sponsor

PDL BioPharma, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00355901

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Visilizumab (Nuvion®; HuM291)

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Time Perspective:

Prospective

Official Title:

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Study Start Date :

Sep 1, 2006

Study Completion Date :

Nov 1, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Previous participation in a visilizumab study of IVSR-UC.
Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.

Exclusion Criteria:

Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
For U.S. sites, unwilling or unable to provide authorization to use protected health information.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	San Francisco	California	United States	94115
2	Gainesville	Florida	United States	32610
3	Atlanta	Georgia	United States	30342
4	Louisville	Kentucky	United States	40202
5	Worcester	Massachusetts	United States	01655
6	Rochester	Minnesota	United States	55905
7	St. Louis	Missouri	United States	63110
8	Manhasset	New York	United States	11030
9	Mineola	New York	United States	11501
10	New York	New York	United States	10021
11	New York	New York	United States	10029
12	Cleveland	Ohio	United States	44106
13	Hershey	Pennsylvania	United States	17033
14	Charleston	South Carolina	United States	29425
15	Salt Lake City	Utah	United States	84107
16	Bedford Park	South Australia	Australia
17	Box Hill	Victoria	Australia
18	Fremantle		Australia	6160
19	Liverpool		Australia	2170
20	Wien		Austria	A-1090
21	Ghent		Belgium	B-9000
22	Leuven		Belgium	3000
23	Roeselare		Belgium	8800
24	Winnipeg	Manitoba	Canada	R3A-139
25	Hamilton	Ontario	Canada	L8N 3Z5
26	Brno		Czech Republic
27	Praha		Czech Republic
28	Amiens Cedex		France	80054
29	Lille		France	59037
30	Paris		France	75010
31	Freiburg		Germany	D-79106
32	Béri Balogh Adám		Hungary	H-7100
33	Vac		Hungary	H-2601
34	Vásvari Pál		Hungary	H-9024
35	Dublin		Ireland
36	Bologna		Italy	40138
37	Amsterdam		Netherlands	1105 AZ
38	Oslo		Norway
39	Tromso		Norway
40	Kharkov		Ukraine	61001